In Brief: Visx
This article was originally published in The Gray Sheet
Executive Summary
Visx: Receives approvable letter from FDA for its Star ophthalmic excimer laser system for use in treating nearsightedness with photorefractive keratectomy. The device was recommended for approval by FDA's Ophthalmic Devices Panel on Oct. 20 ("The Gray Sheet" Oct. 23, I&W-21). FDA's requirements for final approval include submission of certain patient follow-up data, final labeling and protocols for postmarket studies, the firm states. Visx says it plans to submit all of the information before the end of the year...